FDA Inspection
Lupin LimitedLupin Limited – FDA Inspection, Oct 18, 2018
Record Details
This FDA Inspection record concerns Lupin Limited, with an inspection on October 18, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 19307e9d-44c9-4acd-9d20-d09b96f0a73c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1069052
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(c)(4)Top/Middle/Bottom container sampling
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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Other FDA inspections of Lupin Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| June 16, 2017 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
| June 8, 2017 | Not classified | Office of Inspections and Investigations | |
| March 27, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lupin Limited
- FDA Inspection 1275680 - 2025-07-17
- FDA Inspection 1014374 - 2017-06-16
- FDA Inspection 1020760 - 2017-06-08
- FDA Inspection 924395 - 2015-03-27
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